This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 kg / m2). and with weight\> 75 kg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients
excipients and gum arabic
Azienda di Servizi alla Persona
Pavia, Italy
Changes on anthropometric measures
Body weight (Kg)
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on lipid profile
Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)
Time frame: Changes from baseline lipid profile at 90 days
Changes on insulin resistance
Homeostasis Model Assessment (pt) for evaluate insulin resistance il \> 2,4
Time frame: Changes from baseline insulin resistance at 90 days
Changes on Carbohydrate profile
Glycemia (mg/dl)
Time frame: Changes from baseline Carbohydrate profile at 90 days
Changes on Carbohydrate profile
Insulin (mcU/ml)
Time frame: Changes from baseline Carbohydrate profile at 90 days
Changes on safety
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Time frame: Changes from baseline safety at 90 days
Changes on safety
Gamma glutamyl transferase (U/I)
Time frame: Changes from baseline safety at 90 days
Changes on safety
Creatinine (mg/dl)
Time frame: Changes from baseline safety at 90 days
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Changes on anthropometric measures
Waist circumference (cm)
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on anthropometric measures
Body Mass Index (Kg/m2)
Time frame: Changes from baseline anthropometric measures at 90 days
Changes on body composition
Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Time frame: Changes from baseline body composition at 90 days
Changes on oxidative stress
Reactive Oxygen Species (CARR U)
Time frame: Changes from baseline oxidative stress at 90 days
Changes on oxidative stress
Total Antioxidant Capacity (ORAC U)
Time frame: Changes from baseline oxidative stress at 90 days